FDA Recall
Completed
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Recall: Z-0391-2022
·
Initiated November 8, 2021
Recall
- Recall Number
- Z-0391-2022
- Event Number
- 89054
- Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- FEI Number
- 2182208
- Product Code
- NVZ
- Status
- Completed
- Root Cause
- Error in labeling
- Initiated
- November 8, 2021
- Address
- 8200 Coral Sea St Ne, Mounds View, MN, 55112-4391
Description
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator
Reason
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."
Action
On 09-Nov-2021, Medtronic initiated mailing the patient letter, including a corrected Medical Device Identification Card, to impacted patients. In addition, on 08-Nov-2021, physicians following impacted patients were sent a physician letter explaining the correction.
Distribution
US, Canada, Northern Mariana Islands
Quantity
10 Medical Device Cards